Community Health Workers And MHealth to ImProve Viral Suppression Plus (CHAMPS+)

Part of paid clinical trials in Hobson City, Alabama.

Sponsor
Columbia University
Study ID
NCT06472206
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CHW Sessions — BEHAVIORAL
    Sessions with a Community Health Worker (CHW).
  • CleverCap — DEVICE
    The CleverCap pill bottle is an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp to deliver medication adherence reminders.

Study Details

Although global efforts have been made to end the HIV epidemic, there are still some gaps in HIV testing, antiretroviral therapy (ART) adherence, and viral suppression (VS) among people with HIV (PWH). These gaps are particularly prominent in the Deep South of the United States (US), where PWH face challenges in accessing healthcare services. In response, a team of experienced researchers has developed and tested the Community Health Workers And MHealth to ImProve Viral Suppression (CHAMPS) intervention. This intervention uses mobile health (mHealth) technology and a team of community health workers (CHW) to design an intervention to improve ART adherence and VS. The CHAMPS+ intervention adds a CHW delivered supportive risk reduction counseling during periods of non-suppression to prevent HIV transmission. The study will engage the participants by developing culturally relevant materials and retention strategies, evaluating the clinical effectiveness and sustainability of the intervention in Deep South settings, and assessing regionalized implementation factors. Ultimately, the study will test the effectiveness of CHAMPS+ on ART adherence and viral load suppression for PWH in Alabama, Louisiana, and Mississippi.

Key Dates

Start date
Sep 23, 2024
Status verified
Jul 2025
Primary completion
Jul 22, 2027
Completion
Dec 22, 2027

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Control
    The control condition includes standard health services offered at each site. All participants receive referrals to mental health, drug/alcohol treatment, and/or other HIV services as necessary. Standard of care at each site follows the Dept. of Health and Human Services HIV guidelines.
  • Experimental: Intervention CHAMPS+
    Participants randomized to intervention will receive the CleverCap pill bottle, an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp. Additionally, participants will receive 10-12 sessions with CHWs, and sexual health log to keep track of their sexual behavior.

Primary Outcome Measure

Change in Viral Load [ Time Frame: Baseline, 6 month follow up, 12 month follow up. ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Health Services Center, Inc.Hobson CityAlabama36202
Kelly Turner, MS, ADC
Unity Wellness CenterOpelikaAlabama36801
Tracy Wynne, MBA
Louisiana State University Health Sciences Center in New OrleansNew OrleansLouisiana70112
Meredith Clement, MD
Tulane UniversityNew OrleansLouisiana70112
D. Scott Batey, PhD, MSW
[email protected]
(504) 862-3485
University of Mississippi Medical CenterJacksonMississippi39216
Mauda Monger, PhD, MPH

Find similar trials in Hobson City, AL

By condition
HIV
By specialty
Infectious disease
By research site
Health Services Center, Inc.· Hobson City, ALUnity Wellness Center· Opelika, ALLouisiana State University Health Sciences Center in New Orleans· New Orleans, LATulane University· New Orleans, LAUniversity of Mississippi Medical Center· Jackson, MS

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